SPF 30 LIP BALM- titanium dioxide stick

spf 30 Lip Balm by

Drug Labeling and Warnings

spf 30 Lip Balm by is a Otc medication manufactured, distributed, or labeled by Malin and Goetz Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient Purpose

Titanium Dioxide 3.32% Sunscreen

PURPOSE

Uses

• Helps prevent sunburn
• if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

INDICATIONS & USAGE

Stop use and ask a doctor

• If rash occurs

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

When using this product

• Keep out of eyes. Rinse with water to remove

DOSAGE & ADMINISTRATION

Directions

• Apply Liberally and evenly 15 minutes before sun exposure
• Children under 6 months of age: Ask a doctor

Sun Protection Measures

Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun especially from 10 am- 2pm
• Wear long-sleeved shirts, pants, hats & sunglasses
• Reapply after 40 minutes of swimming or sweating
• Immediately after towel drying
• At least every 2 hours

OTHER SAFETY INFORMATION

OTHER SAFETY INFORMATION

Other information

• Protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredients

Hydrogenated Polyisobutene, Ethylhexyl Palmitate, Hydrogenated Styrene/Isoprene Copolymer, Hydrogenated Polydecene, Flavor, Cinnamal, Cinnamyl Alcohol, Coumarin, d-Limonene, Eugenol, Methyl 2 Octynoate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Urolic Acid, Tocopherol, Stearic Acid, Aluminum Hydroxide.

PRINCIPAL DISPLAY PANEL

(Malin+Goetz)

spf 30 lip balm.

Broad Spectrum Mineral Sunscreen

Water Resistant 40 minutes

0.3fl. oz./10ml

INGREDIENTS AND APPEARANCE

SPF 30 LIP BALM 
titanium dioxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53634-129
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CINNAMYL ALCOHOL (UNII: SS8YOP444F)
EUGENOL (UNII: 3T8H1794QW)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
LIMONENE, (+)- (UNII: GFD7C86Q1W)
METHYL HEPTINE CARBONATE (UNII: 0TTP6YT2T3)
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)
COUMARIN (UNII: A4VZ22K1WT)
TOCOPHEROL (UNII: R0ZB2556P8)
URSOLIC ACID (UNII: P3M2575F3F)
CINNAMALDEHYDE (UNII: SR60A3XG0F)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
HYDROGENATED POLYDECENE TYPE I (UNII: U333RI6EB7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53634-129-01	10 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M020	05/01/2023

Labeler - Malin and Goetz Inc (138615930)